Manufacturing Assembler II
$62,400–$72,800 year
On-siteMenlo Park, California, United States
Job Summary
Precisely assemble catheters and medical devices using hand tools, microscopes, and specialized equipment while adhering to Good Manufacturing Practices and quality standards. Perform in-process inspections, functional testing, and accurate documentation of lot traceability to ensure compliance with regulatory requirements. Actively participate in productivity and quality improvement activities, collaborate with engineering teams to implement procedural enhancements, and support validation processes for new assembly methods. Diagnose minor equipment issues to minimize downtime and maintain team quality and productivity targets in a fast-paced cleanroom environment.
Required Qualifications
- High school diploma or equivalent
- 2+ years in medical device assembly
- Experience with catheter manufacturing
- Strong understanding of GMP, FDA, and ISO regulations
- Ability to read and interpret assembly drawings, work instructions, and technical manuals
- Exceptional manual dexterity
- Ability to operate small hand tools, measurement devices, and computer equipment
- Ability to work with small components under a microscope
- Adequate vision (corrective lenses permitted)
- Ability to perform repetitive tasks with hands and fingers
- Ability to lift, carry, push and pull items up to 40lbs
- Ability to perform tasks that require standing and walking for long periods of time up to the entire shift
- Ability to work well under pressure
- Ability to meet multiple and occasional competing deadlines
- Ability to maintain a cooperative working relationship with other people
- Ability to work in a highly detailed environment
- Good organizational, oral and written communication skills
- Ability to represent the Company to both internal and external audiences (Audit)
- Comfortable donning PPE including safety glasses, shoes, gloves, lab coats, or other PPE as needed
- Overtime and weekend work
- Exposure to chemicals used in the manufacturing process
Desired Qualifications
- Hands-on experience with advanced catheter manufacturing processes, including coil winding and/or braiding
- Experience with hydrophilic coating
- Experience with lamination and adhesive bonding
- Ability to perform reliably in a fast-paced, start-up manufacturing environment
- Flexibility to cross-train across multiple processes
- Strong collaboration skills
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